Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline conducted according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD TG 431
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test system

Duration of treatment / exposure:
3 minutes and 1 hour

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
ca. 92
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 3 min. Reversibility: other: not applicable. Remarks: score = viability [% of negative control]. (migrated information)
Irritation / corrosion parameter:
other:
Value:
ca. 9
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 1 h. Reversibility: other: not applicable. Remarks: score = viability [% of negative control]. (migrated information)

Applicant's summary and conclusion

Conclusions:
Based on the observed results and applying the evaluation criteria it was concluded, that rac-1-(3-Methoxyphenyl)ethylamine shows a corrosive potential in the EpiDerm skin corrosivity test under the test conditions chosen. The test method does not yet allow for the differentiation of severity of the effect. The results however indicate moderate corrosivity. For final assignment of a risk phrase at present, further evidence or results from an in vivo study would be needed.
Executive summary:

The potential of rac-1-(3-Methoxyphenyl)ethylamine to cause dermal corrosion was assessed by a single topical application of 50 μL of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™). Two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, each. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as suitable endpoint. The formazan production of the test-substance treated epidermal tissues is compared to that of negative control tissues. The quotient of both values indicates the

relative tissue viability. The EpiDerm skin corrosivity test showed the following results:

The test substance is able to directly reduce MTT. However, this ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of control tissues inactivated by freezing. Viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 92%. Viability of the test-substance treated tissues determined after an exposure period of 1 hour was 9%. Based on the observed results and applying the evaluation criteria it was concluded, that rac-1-(3-Methoxyphenyl)ethylamine shows a corrosive potential in the EpiDerm™ skin corrosivity test under the test conditions chosen. The test method does not yet allow for the differentiation of severity of the effect. The results however indicate moderate corrosivity. For final assignment of a risk phrase at present, further evidence or results from an in vivo study would be needed.